Status:
RECRUITING
Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
Lead Sponsor:
The Metis Foundation
Conditions:
Wound of Skin
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is intended to provide information from subjects who currently have painful, chronically open wounds and assess the pain reduction capacity of KeraStat® Gel with Morphine. In gathering data...
Detailed Description
Chronic wounds pose a serious challenge to wound care professionals, as open and non-healing ulcers are often painful and difficult to treat. Patients are less compliant because of their pain and also...
Eligibility Criteria
Inclusion
- Subjects age 18 or older able to provide informed consent.
- Ulcer size 1-300 cm2
- 4\. Undermining/tunneling \<3 cm from wound margin 5. Grossly free of necrotic and/or infected tissue 6. Baseline minimum of 2 on VAS pain scale
Exclusion
- Subjects who meet any of the following criteria will be excluded from the study:
- Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine
- Wound has heavy or high-volume exudate or necrotic tissue
- Clinical signs of infection or contamination of the wound
- Subjects unable to complete the VAS pain score in pain journal
- Pregnant or nursing
- Prisoner
- Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05217160
Start Date
May 11 2021
End Date
May 31 2022
Last Update
February 1 2022
Active Locations (1)
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1
South Texas Aesthetic and Reconstructive Surgery
San Antonio, Texas, United States, 78229